U.S. patent number 10,357,611 [Application Number 15/865,350] was granted by the patent office on 2019-07-23 for closure piece for a powder syringe, and powder syringe.
This patent grant is currently assigned to VETTER PHARMA-FERTIGUNG GMBH & CO. KG. The grantee listed for this patent is VETTER PHARMA-FERTIGUNG GmbH & CO. KG. Invention is credited to Joachim Glocker, Tilman Roedle.
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United States Patent |
10,357,611 |
Glocker , et al. |
July 23, 2019 |
Closure piece for a powder syringe, and powder syringe
Abstract
A closure piece for a powder syringe is proposed, having a main
body, a sealing element, which is disposed on the main body such
that it rests in a sealing manner against a distal opening of a
powder syringe, when the closure piece is disposed in the closing
position thereof on the powder syringe, and a channel, which passes
through the main body and the sealing element and has a proximal
and a distal end. The closure piece is characterized by a retaining
element, which is configured and/or can be disposed such that,
prior to an activation of the powder syringe, any powder from a
chamber of the powder syringe is at least substantially, preferably
completely, prevented from penetrating the channel, when the
closure piece is disposed in the closing position thereof on the
powder syringe.
Inventors: |
Glocker; Joachim (Weingarten,
DE), Roedle; Tilman (Wolfegg, DE) |
Applicant: |
Name |
City |
State |
Country |
Type |
VETTER PHARMA-FERTIGUNG GmbH & CO. KG |
Ravensburg |
N/A |
DE |
|
|
Assignee: |
VETTER PHARMA-FERTIGUNG GMBH &
CO. KG (Ravensburg, DE)
|
Family
ID: |
45808729 |
Appl.
No.: |
15/865,350 |
Filed: |
January 9, 2018 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20180126081 A1 |
May 10, 2018 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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14002580 |
|
9943648 |
|
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PCT/EP2012/000787 |
Feb 23, 2012 |
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Foreign Application Priority Data
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Mar 3, 2011 [DE] |
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10 2011 013 792 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M
5/31 (20130101); A61M 5/284 (20130101); A61M
5/286 (20130101); A61M 2005/287 (20130101); A61M
2005/3118 (20130101); A61M 5/347 (20130101); A61J
1/1406 (20130101); A61M 2005/312 (20130101); A61M
2005/3106 (20130101); A61J 1/2041 (20150501); A61M
2005/3104 (20130101); A61M 5/345 (20130101) |
Current International
Class: |
A61M
5/31 (20060101); A61M 5/28 (20060101); A61J
1/14 (20060101); A61M 5/34 (20060101); A61J
1/20 (20060101) |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Hayman; Imani N
Attorney, Agent or Firm: Olson; Stephen T. Harness, Dickey
& Pierce, P.L.C.
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation of U.S. patent application Ser.
No. 14/002,580 filed on 30 Aug. 2013, which is a 371 U.S. National
Stage of International Application No. PCT/EP2012/000787 filed 23
Feb. 2012, which claims the benefit of German Patent Application
No. 102011013792.0 filed 3 Mar. 2011. The entire disclosures of
each of the above applications are incorporated herein by
reference.
Claims
The invention claimed is:
1. A closure piece for a powder syringe comprising: a main body; an
elastic sealing element disposed on the main body and resting in a
sealing manner against a distal opening of the powder syringe
between the main body and a wall of the powder syringe when the
closure piece is disposed on the powder syringe in a closing
position thereof; a channel passing through the main body and the
sealing element, the channel having a proximal end and a distal
end; a closure piece cap having a projection passing through the
channel; and a retaining element for at least substantially
preventing powder coming from a chamber of the powder syringe from
penetrating the channel when the closure piece is disposed in the
closing position on the powder syringe, the retaining element being
a closure piece disc configured to rest in a sealing manner against
a narrowing of the powdered syringe to prevent the powder from
penetrating into the channel, wherein the projection holds the
closure piece disc in a sealing contact with the powder syringe
when the closure piece is in the closing position.
2. The closure piece according to claim 1, wherein the projection
includes a rod-like portion passing through the channel of the
sealing element, the closure piece disc proximate an end of the
rod-like portion.
3. The closure piece according to claim 1, wherein the closure
piece disc includes a radially extending protrusion.
4. The closure piece according to claim 1, wherein the closure
piece disc has at least one protrusion on a surface that is
oriented toward the sealing element.
5. The closure piece according to claim 1, wherein the closure
holds the closure piece disc in a sealing contact with the powder
syringe when the closure piece is in the closing position.
6. The closure piece according to claim 1 in combination with the
powder syringe.
7. The combination of claim 6, wherein the powder syringe is
configured as a dual chamber system.
8. The closure piece according to claim 1, wherein the projection
extends in an axial direction and further wherein the closure piece
disc is spaced from the sealing element in the axial direction when
in the closing position.
9. The closure piece according to claim 1, wherein the elastic
sealing element has an outside diameter corresponding to an inside
diameter of a narrowing of the powder syringe.
10. The closure piece according to claim 1, wherein the closure
piece disc is movable toward the elastic sealing element in
response to a pressure generated within the powder syringe.
11. A closure piece for a powder syringe comprising: a main body;
an elastic sealing element disposed on the main body and resting in
a sealing manner against a distal opening of the powder syringe
when the closure piece is disposed on the powder syringe in a
closing position thereof; a channel passing through the main body
and the sealing element, the channel having a proximal end and a
distal end; a closure piece cap for closing the distal end of the
channel; and a retaining element being a closure piece disc for
resting against a narrowing of the powder syringe when the closure
piece is in the closing position; wherein the closure piece cap
includes a rod-like portion passing through the channel and the
closure piece cap holds the closure piece disc in the closing
position, and wherein the elastic sealing element has an outside
diameter corresponding to an inside diameter of a narrowing of the
powder syringe.
12. The closure piece according to claim 11, wherein the closure
piece disc carried at an end of the rod-like portion.
13. The closure piece according to claim 11, wherein the closure
piece disc includes a radially extending protrusion.
14. The closure piece according to claim 11, wherein the closure
piece disc has at least one protrusion on a surface that is
oriented toward the sealing element.
15. The closure piece according to claim 11, wherein the closure
holds the closure piece disc in a sealing contact with the powder
syringe when the closure piece is in the closing position.
16. The closure piece according to claim 11 in combination with the
powder syringe.
17. The combination of claim 16, wherein the powder syringe is
configured as a dual chamber system.
18. A closure piece for a powder syringe in combination with the
powder syringe, the powder syringe including a distal opening and a
narrowing proximate the distal opening, the closure piece
comprising: a main body; an elastic sealing element disposed on the
main body and resting in a sealing manner against the distal
opening of the powder syringe when the closure piece is disposed on
the powder syringe in a closing position; a channel passing through
the sealing element, the channel having a proximal end and a distal
end; a closure piece cap for closing a distal end of the channel;
and a closure piece disc disposed within the powder syringe and
resting against the narrowing of the powder syringe when the
closure piece is in the closing position; wherein the closure piece
cap includes a rod-like projection passing through the channel and
the closure piece cap holds the closure piece disc in the closing
position, and wherein the elastic sealing element has an outside
diameter corresponding to an inside diameter of a narrowing of the
powder syringe.
19. The combination according to claim 18, wherein the closure
piece disc is spaced from the sealing element in the closing
position.
20. The combination according to claim 18, wherein the closure
piece disc includes a radially extending protrusion.
21. The combination according to claim 18, wherein the closure
piece disc has at least one protrusion on a surface that is
oriented toward the sealing element.
22. The combination according to claim 18, wherein the main body
includes a lower portion circumferentially surrounding a distal end
of the powder syringe.
23. The combination of claim 18, wherein the powder syringe is
configured as a dual chamber system.
Description
DESCRIPTION
The invention relates to a closure piece for a powder syringe
according to the preamble of claim 1, as well as a powder syringe
according to the preamble of claim 16.
Closure pieces and powder syringes of the presently mentioned kind
are known in the art. Dual chamber systems having a proximal and a
distal chamber are preferably used as powder syringes. The proximal
chamber typically comprises a liquid solvent and is separated from
the distal chamber by a central plug, which includes a material
that is soluble in the solvent. Said material can be a free-flowing
powder. Known closure pieces include a channel that is in
communication with the distal chamber, on the one hand, and that
can be brought in fluid communication with a cannula or needle of a
syringe that is attached to the closure piece, on the other hand.
It is possible for powder to enter the area of the closure piece
that is provided for the channel and/or into the channel itself.
This can cause clumping, meaning the formation of agglomerates of
the powder-type material, and the material may no longer be
soluble. When this occurs, the channel is blocked such that the
dual chamber system is no longer usable. The same problem also
exists with a powder syringe that is not configured as a dual
chamber system but that includes one closure piece with one
channel. Powder agglomerates can form inside the channel in this
instance as well, thus blocking the channel.
Therefore, it is the object of the present invention to provide a
closure piece for a powder syringe as well as a powder syringe that
do not suffer from the aforementioned disadvantages.
The object is achieved by a closure piece having the characterizing
features as set forth in claim 1. The closure piece for a powder
syringe comprises a main body and a sealing element, with the
sealing element being disposed such on the main element that it
rests in a sealing manner against a distal opening of a powder
syringe, when the closure is disposed in the closing position
thereof on the powder syringe. The closure piece also includes a
channel that passes through the main body and the sealing element.
Said channel includes a proximal and a distal end. The closure
piece is characterized by a retaining element that is configured
and/or disposed such that, prior to the activation of the powder
syringe, any powder coming from a chamber of the powder syringe is
at least substantially, preferably completely, prevented from
penetrating the channel, when the closure piece is disposed in the
closing position thereof on the powder syringe. The wording "at
least substantially" means that at most such a powder quantity can
penetrate the channel that clumping is still precluded from
occurring. The retaining element is configured such that it
prevents the penetration of powder-like material into the channel
of the closure piece, when said closure piece is disposed in the
closing position thereof, or it can--if necessary, also separated
from the remaining elements of the closure piece--be disposed such
that any penetration of powder into the channel is prevented. The
retaining element is preferably disposed such that the incidence of
any residual quantities that could still clump is minimized or
avoided completely, with the latter being particularly preferred.
The retaining element can be, simultaneously, configured
correspondingly as well as with the capacity of being disposed
correspondingly. The retaining element virtually separates the
channel from the powder-containing chamber, such that no
agglomerates can form inside the channel blocking the same. The
functioning of a powder syringe that is provided with the closure
piece is therefore ensured, even over extended storage periods. The
position in which the syringe, with the applied closure piece, is
stored is immaterial, because, due to the retaining element, powder
cannot penetrate the channel irrespective of the respective storage
position, or, if at all, only such quantities are able to enter
that are insufficient to cause clumping.
A closure piece comprising a closure piece cap for closing the
distal end of the channel is preferred, wherein the closure piece
cap includes a rod-like projection. Said projection passes through
the channel, and wherein the retaining element is provided thereon.
The rod-like projection is thus quasi a locking means for the
channel. The advantage therein lies in the fact that when the
closure piece cap is removed to activate the powder syringe the
channel is released at the same time, without any need for further
steps. Moreover, a closure piece that already comprises a closure
piece cap does not require any further elements.
Also preferred is a closure piece that includes a retaining element
that is configured as a slotted membrane. The pressure forces that
are generated when activating the syringe and/or releasing the
content of the syringe into a patient can burst open and deform the
membrane, and the membrane can be perforated by the needle-like
device or dilated in the region of the slot in order to release the
channel.
Further preferred is a closure piece with a retaining element that
is configured as a displaceable element in the direction along the
channel. In the storage state of the syringe, said element is
disposed quasi at the proximal end of the channel and closes the
same. To activate the powder syringe, the element can be displaced
along the channel toward the distal end thereof, where it finally
exits the channel, thereby releasing the channel.
Also preferred is a closure piece where the retaining element
comprises a soluble substance. It is especially preferred for the
retaining element to comprise a lyophilized substance. When the
syringe is activated, said substance can be dissolved by a solvent,
thereby releasing the channel.
Finally, also preferred is a closure piece where the retaining
element comprises a closure piece disc that is configured such that
the disc has the capacity to rest in a sealing manner against a
narrowing of the powder syringe. This way, said disc is able to
prevent powder from penetrating into the channel. The closure piece
disc can be disposed particularly in the region of the narrowing of
the powder syringe in such a manner that, prior to the activation
of the powder syringe, no powder is able to penetrate into the
channel. When the powder syringe is activated, a closure piece disc
is displaced from the narrowing, such that the fluid path to the
channel is released.
Further embodiments can be derived from the dependent claims.
The present object is also achieved in that a powder syringe with
the characterizing features of claim 16 is provided. Said syringe
includes a distal opening and is characterized in that it is
provided with a closure piece according to any one of the claims 1
to 15. Due to the closure piece that comprises a retaining element
for the powder, the powder syringe can be stored for any length of
time and in any position, and without clumping risk involving
powder inside the channel, because the powder is held back by the
retaining element.
Preferably, the powder syringe is configured as a dual chamber
system.
Especially preferred is a powder syringe with a narrowing in the
region of the distal end thereof.
The invention will be explained in further detail below based on
the drawings. Shown are as follows:
FIG. 1 is a powder syringe that is configured as a dual chamber
system having a first embodiment of the closure piece;
FIG. 2 is a detail view of the embodiment of a closure piece
according to FIG. 1;
FIG. 3 is a second embodiment of a closure piece;
FIG. 4 is a sectional view of an embodiment according to FIG. 3
along the line A-A;
FIG. 5 is a third embodiment of the closure piece;
FIG. 6 is a slight variation of an embodiment with regard to FIG. 5
of a closure piece on a powder syringe in the activated state;
FIG. 7 is a sectional view of an embodiment according to FIG. 6
along the line A-A;
FIG. 8 is a fourth embodiment of a closure piece;
FIG. 9 is the embodiment according to FIG. 8 in the activated
state;
FIG. 10 is a fifth embodiment of a closure piece, and
FIG. 11 is the embodiment according to FIG. 10 in activated
state.
FIG. 1 shows a powder syringe 1 provided with a representation of a
first embodiment of a closure piece 3. The powder syringe 1
includes a proximal end 5 and a distal end 7. A distal opening 9 is
provided on the distal end 7. A proximal opening 11 is provided on
the proximal end 5. A finger rest 13 is disposed in the area of the
proximal opening 5 that includes a passage for a piston rod, which
is presently not shown.
In the shown embodiment, the powder syringe 1 is configured as a
dual chamber system. During the production of this syringe, a
central plug 15 is inserted through the proximal opening 11 into
the interior of the powder syringe 1, which then divides a proximal
chamber 17 from a distal chamber 19. The distal chamber 19 is
preferably filled through the distal opening 9. For example, it is
possible to fill in a dissolved active substance or a combination
of dissolved active substances, meaning it is possible to fill in a
solution that is afterwards lyophilized. Subsequently, the distal
chamber 19 or the distal opening 9, respectively, is closed by
means of the closure piece 3. A lyophilisate cake that is disposed
in the distal chamber 19 typically adheres to a wall 21 of the
powder syringe 1, such that it is not freely movable inside the
distal chamber 19.
If a powder-like, soluble substance is filled into the distal
chamber 19 instead, said substance is able to distribute itself
freely therein. The distal chamber 19 is closed by means of a
closure piece 3. The powder is then able to reach a channel region
of the closure piece 3 and may form insoluble agglomerates therein.
These agglomerates clog the channel and compromise the
functionality of the powder syringe 1.
A solvent can be filled into the proximal chamber 17 through the
proximal opening 11, and afterwards this opening is closed by means
of an end plug 23. The end plug 23 preferably includes coupling
means 25 for a coupled connection to a piston rod that is presently
not shown. In the depicted embodiment, the coupling means 25 is an
internal thread that is able to mesh with the outside thread of the
piston rod, which is presently not shown.
Correspondingly, preferably a powder 27 is present in the distal
chamber 19 of the powder syringe 1, which is presently configured
as a dual chamber system. The proximal chamber 17 preferably
contains a solvent 29. The powder 27 is preferably soluble in the
solvent 29.
In the area of the distal chamber 19, the wall 21 includes a radial
projection, that extends--seen in the circumferential
direction--only over a relatively small angular range and that is
configured as the bypass 31. To activate the dual chamber system,
the end plug 23 is displaced, aided by the piston rod that is not
shown, in the direction of the distal end 7. wherein, due to the
pressure forces that have developed inside the proximal chamber 17,
the middle plug 15 is also displaced in this direction.
The present description refers generally to a longitudinal
direction that corresponds to the longitudinal extension of the
powder syringe 1. A radial direction refers, correspondingly, to a
direction that is perpendicular in relation to said longitudinal
direction. The longitudinal direction is also referred to as the
axial direction. A circumferential direction extends along a
circumferential line around the longitudinal axis of the powder
syringe 1.
The bypass 31 has--seen in the longitudinal direction--an extension
that is larger than the axial length of the central plug 15. This
is the reason why, when the central plug 15 is displaced into the
bypass region 31, a fluid connection is established between the
proximal chamber 17 and the distal chamber 19 via the bypass 31.
The solvent 29 is then introduced, particularly by means of a
further displacement of the end plug 23 from the proximal chamber
17 into the distal chamber 19, where it dissolves the powder 27.
Finally a state is reached where the central plug 15 and the end
plug 23 rest against each other. By a displacement of the two plugs
toward the distal end 7, it is now possible for the solution, that
is present in the distal chamber 19, to be expelled from the powder
syringe 1, and preferably injected into a patient. The
configuration and functionality of such dual chamber system is
known from the prior art, which is why it will not be discussed in
further detail.
In a dual chamber systems that must take up powder in the distal
chambers thereof, the distal opening 9 is preferably expanded, in
comparison to dual chamber systems that are envisioned for
lyophilisates, because, this way, the powder filling process is
facilitated, while a smaller diameter is sufficient for a
solution.
The invention is not limited to powder syringes that are configured
as dual chamber systems. Basically any powder syringe suffers from
the problem whereby a powder, that is present inside a chamber of
the syringe, can clump inside a channel of a closure piece.
Correspondingly, the presently proposed solution is applicable with
regard to any powder syringe. It has also been demonstrated that a
lyophilisate, which is present inside the distal chamber of a dual
chamber system, may pulverize at least in part over the course of
the storage period, thereby acquiring the potential for clogging
the channel of a closure piece. Consequently, it is understood that
the proposed closure piece can be used, preferably, also in dual
chamber systems that comprise a lyophilisate in the distal chambers
thereof.
FIG. 2 shows a detail view of the representation of the embodiment
of the closure piece 3 according to FIG. 1. Same and functionally
identical elements are identified by the same reference signs, such
that presently reference is made to the preceding description. The
closure piece 3 includes a main body 33. A sealing element 35 is
disposed thereon in such a fashion that it rests in a sealing
manner against the distal opening 9 of the powder syringe 1, when
the closure piece 3 is in the presently depicted closing
position.
The sealing element 35 is made of an elastic material and is quasi
clamped between the wall 21 of the powder syringe 1 and the main
body 33 of the closure piece 3, such that there results a sealing
effect. In the presently depicted embodiment, a mouth region 37 of
the powder syringe 1 has an internal contour to which an external
contour of the sealing element 35 is adjusted such that said
element rests alongside the entire mouth region 37, when the
closure piece 3 is in the closing position.
Edges of the sealing element 35 in FIG. 2 are in part depicted as
overlapping with edges of the main body 33 and the wall 21. This is
nothing more than an artefact in the assembly of the technical
drawing, where the sealing element 35 is shown in the
non-compressed state thereof between the main body 33 and the wall
21. In reality, the sealing element is compressed, then resting
tightly against the main body 33 and the wall 21. Had this state
been depicted realistically here, the corresponding edges would lie
against each other, without overlapping.
The main body 33 includes at the end thereof that is oriented
toward the distal chamber 19 the radial protrusions 39, 39', which
are directed toward the inside. By said protrusions, the main body
reaches behind a flange 41 of the powder syringe 1, which is
provided in the mouth region 37 such that an undercut or groove 43
is quasi formed in the wall 21. In the closing position of the
closure piece 3, the protrusions 39, 39' engage therein, quasi in
the fashion of latch noses. This way, it is possible to introduce
forces into the sealing element 35 that compress said sealing
element and facilitate the tight contact position in the area of
the distal opening 9 and/or in the mouth region 37. Simultaneously,
the protrusions 39, 39' hold the closure piece 3 safely in place on
the main body of the powder syringe 1 that is constituted by the
wall 21.
If the closure piece 3 is used in connection with a lyophilisate
that is provided inside the distal chamber 19, the flange 41
preferably comprises an annular-like groove that reaches around
it--seen in the circumferential direction. The projections 39, 39'
can also engage in a latching manner in this groove, which is
presently not shown. In the view as represented in FIG. 2, as
further latch position is configured quasi above the depicted latch
position of the closure piece 3, and in which, not only, is the
sealing element 35 not compressed but it also leaves a gap in the
area of the distal opening 9, such that there is fluid
communication from the distal chamber 19 to the environment of the
powder syringe 1. It is possible to lyophilize a solution that is
provided in the distal chamber 19, while the closure piece 3 is
disposed in the top latch position thereof. After the
lyophilization process is complete, the closure piece 3 is brought
into the latch position as depicted in 2, from where it closes
distal chamber 19 in a sealing manner.
The closure piece 3 includes a channel 45 that passes through the
main body 33 and the sealing element 35. The channel 45 includes a
proximal end 47 and a distal end 49.
In known closure pieces it is possible for powder-like material
from the distal chamber 19 to penetrate the channel 45 via the
proximal end 47. Clumping can occur at this location, and the
agglomerates may be insoluble and thereby impair the functionality
of the powder syringe 1.
To prevent this from occurring, the closure piece 3 includes a
retaining element 51 that is configured and/or can be disposed in
such a manner that, at any rate, prior to the activation of the
powder syringe, no powder from the distal chamber 19 is able to
penetrate the channel 45, when the closure piece 3 is disposed in
the closing position on the powder syringe, as shown in FIG. 2.
In the depicted representation of the embodiment, the closure piece
3 includes a closure piece cap 53 that closes the distal end 49 of
the channel 45.
The closure piece cap 53 preferably comprises a rod-like projection
55. Said projection passes through the channel. The retaining
element 51 is provided on the projection 55.
For example, it is possible to configure the preferably rod-like
projection 55 having a diameter that is greater than the diameter
of the section of the channel 45 that passes through the sealing
element 35. The sealing element 35 is then compressed, when the
projection 55 is inserted in the corresponding channel section, and
it rests correspondingly against the same in a sealing manner. If
the projection 55 then includes an extension--seen in the
longitudinal direction--that reaches all the way to the proximal
end 47, the channel 45 is tightly sealed, such that no powder is
able to penetrate into the channel.
It is disadvantageous, however, that, due to the friction between
the projection 55 and the sealing element 35, great force is needed
to remove the closure piece cap 53 in the embodiment having a
rod-like projection along the totality of the longitudinal
extension with a corresponding diameter.
Therefore, an embodiment where the retaining element 51 is
configured as a thickening 57 of the rod-like projection is
preferred. In the depicted preferred embodiment, the thickening 57
is provided on the end of the projection 55 that is oriented toward
the distal chamber 19. Preferably, the projection 55 passes through
the entire sealing element 35, such that it extends at least
partially from the proximal end 47 of the channel 45 by the
thickening 57 thereof. In the region of the thickening 57, which
preferably has a greatest diameter, that is greater than the inside
diameter of the section of the channel 45 that is provided on the
inside of the sealing element 35, the sealing element 35 rests
there-against in a sealing manner, such that the proximal end 47 is
tightly sealed. No powder can therefore penetrate into the channel
45.
If a retaining element is provided in form of a thickening 57 and
is part of the projection, the diameter of the projection can be
configured as smaller outside of the thickening 57 than the inside
diameter of the section of the channel 45 inside the sealing
element 35. This causes a reduction of the frictional forces that
are generated when removing the closure piece cap 53.
It is possible to configure the projection 55 as having a larger
diameter in the area in which said projection exits from the
sealing element 35 opposite to the proximal end 47, thereby tightly
sealing the portion of the channel 45 that extends through the
sealing element 35 as well. In this case, the inlet and outlet of
the channel 45 to and from the sealing element 35, respectively,
are tightly closed by the projection 55.
It can be discerned further based on FIG. 2 as follows: the main
body 33 preferably includes a shoulder 59 that serves for the
coupling action with a cannula or a needle of a syringe. In
particular, it is possible to configure the shoulder 59 as tapered.
A configuration as a Luer cone is especially preferred.
Correspondingly, it is possible for the main body 33 to include a
Luer thread 61 that reaches around the shoulder 59, serving to
create a coupling with dispensing means for dispensing an active
substance or a solution. Luer cones and Luer threads are known in
the art and will therefore not be discussed in further detail.
Preferably, the closure piece cap 53 further includes a wall
section 63 that reaches around the shoulder 59. At the end thereof
that is oriented toward the distal chamber 19, there is provided a
radially extending projection 65--seen in the circumferential
direction. Said projection is preferably engaged in the Luer thread
61, such that the closure piece cap 53 can be screwed into the Luer
thread or out of the Luer thread, respectively.
FIG. 3 shows a representation of a second embodiment of a closure
piece 3. Same and functionally identical elements are identified by
the same reference signs, such that presently reference is made to
the preceding description. For better clarity, not all reference
signs are reflected but only those that are directly referenced in
the description. In the embodiment that is represented in FIG. 3,
the retaining element is configured as a membrane 67. The membrane
can be configured such that, in principle, the membrane can be
perforated or torn, it can burst, particularly when it is subjected
to pressure forces, or it can be destroyed in another way.
Destructible membranes, particularly membranes that can be
perforated or burst open, suffer from the disadvantage that small
particles come loose from the membrane, when the membrane is
opened, which may be injected into the patient. In the depicted
embodiment, the membrane 67 is, therefore, preferably configured as
a slotted membrane. This means it includes at least one slot 69,
where the membrane can be dilated when pressure forces are applied.
The slot can be originally formed as part of a preferably
originally injection-molded membrane, meaning the slot is generated
during the injection-molding process. Preferably, it is also
possible to incorporate the slot after the production of the
membrane, for example by means of a cutting step, preferably a
laser cutting step. It is preferred that the slot is so narrow in
the closed state thereof that no powder is able to penetrate
through it. However, it is also possible that only such a minimal
powder quantity is able to penetrate through the slot that any
clumping inside the channel 45 is still precluded. An embodiment of
this type also falls within the scope of protection of the
subject-matter of the present invention.
In the shown representation of the embodiment, the sealing element
35 is configured as shorter--seen in the axial direction--than in
the embodiment according to FIG. 2. In particular, presently, it
does not include a contour that extends into the mouth region 37
and follows that contour. Similarly, it is also possible to provide
a preferably slotted membrane in the context of a sealing element
that is configured as shown in FIG. 2.
However, in the depicted embodiment, the sealing element 35 extends
through the entire shoulder 59 of the main body 33. It even reaches
over the shoulder 59--seen in the axial direction--and forms an
annular support region 71 at the distal end thereof.
The closure piece cap 53 presently rests in a sealing manner,
together with the wall section 63, against the shoulder 59. It only
has a short central projection 73 that extends, over a
comparatively short distance, into the channel 45, resting tightly
against the sealing element 35.
The main body 33, and therefore also the shoulder 59, comprises
material, and/or it is made of material that is typically not
suited for primary contact. This means that the medication is not
allowed to come into contact with the main body 33, particularly
during storage. This is the reason why the closure piece cap 53
typically includes a projection 73 that extends--seen in the axial
direction--at least far enough that it ends resting in a sealing
manner against the sealing element 35. This way, it is avoided that
a material that is provided in the distal chamber 19 comes into
contact with the material of the main body 33. If the sealing
element 35 extends, however, through the entire shoulder 59--as in
the representation of the embodiment that is shown in FIG.
3--forming an annular support region 71 even beyond the same, it is
not necessary to provide a long projection 73 on the closure piece
cap 53. Instead, it is sufficient for said projection to be
configured such that is engages, still in a sealing manner, with
the support region 71. This way, it is ensured that any substance
provided inside the distal chamber 19 will not come into contact
with the material of the main body 33.
It can also be discerned as follows: in the closing position of the
closure piece 3, the protrusions 39, 39' are pressed into the latch
position of the groove 43 by a safety cap 79. The safety ring 75 is
connected to a safety cap 79 by the tear-off bars 77, and said cap
reaches over and around the closure piece cap 53. When applying the
closure piece 53, the main body 33 is first displaced into the
closing position thereof, subsequently, the safety ring 75 is
pushed over the same by means of the safety cap 79, such that the
main body 33 is ultimately safely held in the latched position
thereof. To open the closure piece 3, the safety cap 79 is
separated from the safety ring 75 in the area of the tear-off bars
77 and then removed. The closure piece cap 53 can then be removed
to create a fluid communication between of the environment of the
powder syringe 1 and the channel 45.
FIG. 4 is a sectional view of the embodiment according to FIG. 3
along a line A-A. Same and functionally identical elements are
identified by the same reference signs, such that presently
reference is made to the preceding description. The outer area
shows the safety ring 75 that reaches around the main body 33. It
is illustrated therein that the main body 33 includes a plurality
of slots or recesses, respectively, in the area of the sectional
plane, and particularly in the area of the protrusions 39,
39'--seen in the circumferential direction--that extend over a
certain area--seen in the axial direction. Solely by way of an
example, two slots are identified herein by the reference numerals
81, 81'. Overall, a total of eight slots or recesses, respectively,
is provided in FIG. 4 along the circumference of the main body.
Said recesses ensure, on the one hand, that the main body 33 has
sufficient elasticity in the area of the protrusions 39, 39' to be
pushed over the flange 41 prior to the protrusions 39, 39' engaging
in the groove 43. On the other hand, the recesses are essential,
when the closure piece 3 is used in conjunction with a dual chamber
system that has a lyophilisate provided in the distal chamber 19
thereof. As previously explained, the closure piece 3 is preferably
disposed in the top latch position during the lyophilization, where
it does not provide a tight seal for the distal opening 9 of the
dual chamber system. The fluid path that the evaporating solvent
can take during the freeze-drying process from the distal chamber
19 and the distal opening 9, able to reach the environment of the
dual chamber system, then follows such recesses, particularly also,
as shown by way of an example, by the slots identified with the
numerals 81, 81'.
The membrane 67 is disposed in the center of the representation in
FIG. 4. Said membrane includes two slots 83, 83' that are
perpendicular in relation to each other, such that a cross-shaped
slot design is created. It is possible for the membrane 67 to have
only one slot. More than two slots are conceivable as well. If two
slots are provided, they do not have to be disposed at a right
angle. In principle, any number and any geometric slot arrangement
is possible.
The essential aspect is that the width of the slots and/or an
opening that is disposed in the center of the presently crosswise
arranged slot design, that includes the slots 83, 83', is smaller
than the mean grain size of the powder that is provided inside the
distal chamber 19. Preferably, the opening or the width of the
slot, respectively, is smaller than the smallest grain size of said
given powder. This way, it is ensured that the membrane 67 acts as
a retaining means 51 and efficiently prevents any powder from
penetrating the channel 45. When the powder syringe is activated,
which means a solution that is present in the distal chamber 19 is
slated for injection, the membrane 67 is dilated such that, due to
the pressure forces that have developed inside the distal chamber
19, is releases a fluid path to the channel 45 at least in the area
of the slots 83, 83'. It is also possible that the membrane 67
tears open, due to the effect of the pressure forces, preferably
along the slots 83, 83', such that a fluid path having a larger
diameter is released.
In the embodiment that is presently shown, the membrane 67 is
configured in one piece with the sealing element 35. It is also
possible to provide the same as a separate element. In such a case,
said membrane is preferably connected to the sealing element 35 in
a suitable manner. It is especially preferred that the membrane 67
is disposed on the proximal end 47 of the channel 45.
FIG. 5 is a representation of a third embodiment of a closure piece
3. Same and functionally identical elements are identified by the
same reference signs, such that presently reference is made to the
preceding description. The retaining element 51 herein is
configured as an element that is displaceable along the channel 45.
In the depicted embodiment, the displaceable element is a ball 85.
Said ball has a diameter that is larger than the diameter of the
section of the channel 45 that is disposed inside the sealing
element 35. This way, it is possible to seal the proximal end 47 by
means of the ball 85. Friction holds the ball 85 in the closing
position thereof.
In other embodiments, the displaceable element can have a different
geometry. For example, it is possible to provide at least one
protrusion on the ball 85 that extends beyond the proximal end 47
and into the distal chamber 19. This way, the channel 45 can also
be directly closed off at the proximal end 47. Instead of the ball
85, it is also possible to envision, for example, a cylindrical
element. Said element can also include a corresponding protrusion.
Any alternative geometries are possible.
The displaceable element preferably comprises glass or is made of
glass. It has the necessary hardness, such that the sealing
elements 35 can rest there against in a sealing manner. In
addition, glass is a suitable primary contact material.
In the depicted representation of the embodiment, a holding means
87 is provided for the displaceable element on the proximal end 47.
Said holding means prevents the displaceable element from
penetrating the distal chamber 19. The holding means 87 is
configured as a radial protrusion from a wall of the channel 45 in
the represented embodiment against which the ball 85 comes to rest.
If the displaceable element includes a protrusion, said protrusion
can also extend through the area of the holding means 87, such that
this region is protected against any penetrating powder from the
distal chamber 19. A residual volume of the channel 45, where
clumping could still occur, is not only minimized in this manner
but substantially prevented, or completely altogether.
When pressure forces are introduced into the distal chamber 19 to
activate the powder syringe 1, the displaceable element moves
inside the channel 45 and away from the distal chamber 19. Finally,
it exits from the channel at the distal end 49 thereof.
It is disadvantageous herein that the displaceable element is then
either flushed from the powder syringe 1, wherein, in the worst
case scenario, it is injected into a patient, or it blocks a
cannula or a needle of a syringe and/or closes off the inlet
thereto. Therefore, a retaining means is preferably provided for
retaining said displaceable element while, simultaneously,
releasing a fluid path in the environment of the powder syringe 1.
A retaining means of this kind can be provided in a specially
manufactured cannula attachment. However, this is, comparatively
speaking, a complex and expensive solution, because it is not
possible, if this is done, to use the closure piece 3 or the powder
syringe 1 in conjunction with conventional cannulas and/or syringe
needles.
FIG. 6 shows a representation of an embodiment that is a slight
variation of the embodiment of the closure piece 3 in the activated
state as depicted in FIG. 5. Same and functionally identical
elements are identified by the same reference signs, such that
presently reference is made to the preceding description. A
retaining means 89 for the displaceable element is presently
provided in the area of the distal end 49 of the channel 45. A
cannula 91 is disposed on the shoulder 59. Said cannula preferably
comprises an internal cone that is able to function in conjunction
with a shoulder 59, which is preferably configured as tapered, such
that a tight connection is ensured from the powder syringe 1 to the
cannula 91. The retaining means 91 quasi catches the displaceable
element. Simultaneously, however, the fluid path from the channel
45 to the cannula 91 remains intact. In particular, an injection
solution is able herein to circumflow the displaceable element that
is presently configured as a ball 85.
The functionality of the retaining means 89 is explained in further
detail based on the sectional view as depicted in FIG. 7 along a
line A-A in FIG. 6. Same and functionally identical elements are
identified by the same reference signs, such that presently
reference is made to the preceding description. The Luer thread 61
is depicted in the outer region of FIG. 7. Toward the inside--seen
in the radial direction--then follows a wall section of cannula 91.
Further radially inside, the shoulder 59 is finally shown. Again,
there appears to be overlap that is the result of fact that the
state of assembly of the elements in the drawing was drawn based on
the disassembled configuration thereof. Any dilation or compression
of materials occurring during the assembly of the different
elements was presently not taken into consideration, which is why
there seem to be overlaps in some regions.
In the area of the distal end 49, the shoulder 59 includes the
radial protrusions 93, 93', 93''' that project deeply enough into
the channel 45 for retaining the displaceable element or the ball
85, respectively. Three radial protrusions 93, 93', 93'' are
provided in the depicted representation of the embodiment--seen in
the circumferential direction. A single radial protrusion is
ultimately sufficient if it radially extends far enough to the
inside to be able to retain the ball 85. Two or more than three
protrusions are possible as well. The essential aspect--seen in the
circumferential direction--is that the free spaces 95, 95', 95''
are preserved, which will allow for a fluid communication between
the channel 45 and an environment of the powder syringe 1 or the
cannula 91, respectively. An injection solution is thus able to
flow around the ball 85 or the displaceable element, respectively,
exit the channel 45 through the free spaces 95, 95', 95'' and enter
the environment of the powder syringe 1 or the cannula 91,
respectively.
FIG. 8 is a representation of a fourth embodiment of the closure
piece 3. Same and functionally identical elements are identified by
the same reference signs, such that presently reference is made to
the preceding description. The retaining element herein comprises a
soluble substance 97. Said substance is selected in such a manner
that it is soluble in the same solvent as the powder, or possibly
the lyophilisate, which must be dissolved and that is present in
the distal chamber 19. It is particularly preferred when the
soluble substance 97 is a lyophilized substance. Using a device,
which is presently not shown, it is possible to bring the solution
into the sealing element 35 and lyophilize said solution therein in
order to form a lyophilisate cake that blocks the channel 45.
In the depicted preferred embodiment, an extension 99 is provided
in the region of the proximal end 47 for receiving the substance
97. It quasi forms a plug that blocks the channel 45 and thereby
prevents the powder, which is present in the distal chamber 19,
from penetrating into the channel.
The functionality of this embodiment will be illustrated in further
detail based on FIG. 9. Same and functionally identical elements
are identified by the same reference signs, such that presently
reference is made to the preceding description. When the powder
syringe 1 is activated, the solvent 29 reaches the distal chamber
19. Inside said chamber, the powder 27 is dissolved in the solvent
29. The solution then reaches the extension 99 via the proximal end
47, where the substance 97 is present. Due to the fact that said
substance is also soluble in the solvent 29, it is dissolved, as
shown in FIG. 9. This means that the plug, which had blocked the
channel 45 gradually dissolves, such that finally the fluid
connection from the distal chamber 19 to the channel 45 has been
released. In the end, the injection solution can be conveyed to the
cannula 91 and from there into a patient.
It is possible for the substance 97 to comprise excipients such as,
for example, vitamin C. In addition, it is possible to add to the
active substance, which is present in the distal chamber 19,
further excipients that are quasi-supplied by the auxiliary
substance 97, which is provided as retaining element 51.
Preferably, the substance 97 can also be incorporated in the
sealing element 35 as a pellet, preferably in the extension 99. If
this is the case, the additional lyophilization step for the
substance 97 can be omitted.
Based on FIG. 9, it can be further discerned as follows: by way of
an example, a ring groove 101 is shown in the area of the flange
41, and the protrusions 39, 39' of the main body 33 engage therein
in the top latch position thereof, when a substance is lyophilized
in the distal chamber 19.
FIG. 10 is a representation of a fifth embodiment of the closure
piece 3. Same and functionally identical elements are identified by
the same reference signs, such that presently reference is made to
the preceding description. The retaining element 51 herein
comprises a closure piece disc 103. The closure piece disc can be
disposed in such a manner that it closes the distal chamber 19,
such that no powder is able to enter the channel 45.
The powder syringe 1 preferably comprises a narrowing 105 in the
mouth region 37. In this area, the wall 21 jumps radially to the
inside, such that the narrowing 105 is formed. Preferably, the
closure piece disc 103 is constituted such that it is able to rest
in a sealing manner against the narrowing 105. To this end, it
preferably includes a radially extending protrusion 107--seen in
the circumferential direction. In a region 109--seen in the axial
direction--following the protrusion 107, the closure piece disc 103
preferably has an outside diameter that corresponds to the inside
diameter of the narrowing 105. Correspondingly, the external
contour of the closure piece disc 103 quasi follows the internal
contour of the narrowing 105 or of the mouth region 37,
respectively, such that it rests by the protrusion 107 and the
region 109 in a sealing manner against the wall 21.
In the depicted embodiment as well, the closure piece cap 53
preferably includes a rod-like protrusion that is presently
configured as a safety pin 111 and that passes through the channel
45. With an applied closure piece cap 53, said pin rests in the
closing position of the closure piece 3 against the closure piece
disc 103 and holds the same in a sealing contact against the
narrowing 105.
The narrowing 105 is preferably provided in the area of the distal
end 9 of the powder syringe 1.
The closure piece disc 103 is preferably comprised of rubber or
TPE; it is especially preferred when it is made of at least one of
these materials. In that case, it has good sealing properties;
moreover, the named materials are suitable for primary contact.
FIG. 11 is a representation of an embodiment according to FIG. 10
in the activated state. Same and functionally identical elements
are identified by the same reference signs, such that presently
reference is made to the preceding description. To activate the
powder syringe 1, first the closure piece cap 53 and thereby the
safety pin 111 are removed. Afterwards, a pressure is generated
inside the distal chamber 19 that pushes the closure piece disc 103
toward the sealing element 35. Said disc includes on a surface 113,
which is oriented toward the sealing element 35, at least one
protrusion, presently these are three protrusions 115, 115', 115''.
By these protrusions, the disc supports itself against the
counter-surface 117 of the sealing element 35. Correspondingly, due
to the protrusion 115, the surface 113 and the counter-surface 117
are held at a distance relative to each other, such that a fluid
path is formed between the same and the protrusions 115, 115',
115''. The solution that exits from the distal chamber 19 is thus
able to flow around the closure piece disc 103 and enters the
channel 45. From there, it can be dispensed to the cannula 91.
Overall, it can be discerned that the presently proposed closure
piece and the presently proposed powder syringe prevent any
clumping risk inside the channel 45 by providing the retaining
element 51. This translates into a considerable contribution to the
improvement of the shelf-life of powder syringes, particularly of
powder syringes with a dual chamber system, thereby ensuring the
functionality of powder syringes even after long storage
periods.
* * * * *